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Completed

NCT Number: NCT02637453

Addition of Six Short Lines on Pulmonary Vein Isolation

We randomly assigned 390 patients with symptomatic, paroxysmal AF to undergo catheter ablation with PVI (PVI group) alone or combined with 6 additional ablation lines extended outside the PVI circumferences at 1, 3 and 6 o'clock of left PV and 6, 9 and 11 o'clock of right PV (PVI+6L group). Patients received monthly 12-lead electrocardiogram, 24-hour Holter at 3, 6 and 9 months and 14-days continuous monitoring at 12 months to detect atrial tachyarrhythmia. The follow-up period was 12 months. The primary end point was freedom from AF recurrence between 91 and 365 days after catheter ablation. The secondary end points included the AF burden, procedural parameters, and complications.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xinhua Hospital, Shanghai Jiao Tong University School of Medicne

Shanghai, Shanghai Municipality, 200092, China

About this study

We randomly assigned 390 patients with symptomatic, paroxysmal AF to undergo catheter ablation with PVI (PVI group) alone or combined with 6 additional ablation lines extended outside the PVI circumferences at 1, 3 and 6 o'clock of left PV and 6, 9 and 11 o'clock of right PV (PVI+6L group). Patients received monthly 12-lead electrocardiogram, 24-hour Holter at 3, 6 and 9 months and 14-days continuous monitoring at 12 months to detect atrial tachyarrhythmia. The follow-up period was 12 months. The primary end point was freedom from AF recurrence between 91 and 365 days after catheter ablation. The secondary end points included the AF burden, procedural parameters, and complications.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients between the ages of 18 and 80 years undergoing their first ablation of atrial fibrillation.
  • Diagnosed with symptomatic paroxysmal atrial fibrillation, defined as an documented episode of atrial fibrillation that lasts more than 30 seconds and terminates in less than 7 days.
  • Resistant or intolerant to at least one class I, II, or III antiarrhythmic drugs.
  • Patients deemed candidates for radiofrequency ablation of atrial fibrillation.
  • Able and willing to comply with pre-, post-, and follow-up requirements.

Exclusion criteria

  • Left atrial thrombus by pre-procedural imaging.
  • Uncontrolled heart failure: New York Heart Association Class III or IV, or left ventricular ejection fraction< 40%
  • Myocardial infarction, unstable angina, coronary stenting within the previous 90 days.
  • Stroke or any thrombo-embolic events within the previous 90 days.
  • Expecting cardiac transplantation or other cardiac surgery within 180 days.
  • History of catheter ablation of atrial fibrillation, atrial flutter or atrial tachycardia.
  • History of blood clotting or bleeding abnormalities.
  • Contraindication to anticoagulation.
  • History of cardiac surgery.
  • Uncontrolled maligment tumor.
  • Patients in dialysis or creatinine > 221 μmol/L.
  • Patients with alanine aminotransferase > 150 U/L or aspartate aminotransferase > 76 U/L
  • Acute illness or active infection at time of index procedure or leukocytosis for which antibiotics have been or will be prescribed.
  • Life expectancy less than 1 year.
  • Women who are pregnant or who plan to become pregnant during the study.
  • Other significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment

Treatment and study plan

PVI

Procedure

Pulmonary vein isolation

CPVI+6L

Procedure

After PVI, 6 ablation lines were added with an extension from pulmonary vein ostium at 1, 3 and 6 o'clock (from internal view) of left PV and 6, 9 and 11 o'clock of right PV

Primary outcomes

  1. Freedom from AF recurrence between 91 and 365 days

    Time frame: 91 to 365 days

    AF recurrence was defined by AF (including atrial flutter or atrial tachycardia) of 30 seconds or more captured by ECG monitoring or any clinical presentation with AF outside the 90-day blanking period (between 91 and 365 days). Cardioversion, or use of class I or III antiarrhythmic drugs outside blanking period was also considered as AF recurrence.

Secondary outcomes

  1. AF burden

    Time frame: 12 months

    Percentage of time in AF, atrial flutter or atrial tachycardia on 14-days continuous monitoring at 12 months.

  2. Procedural time

    Time frame: Within procedure

    Total procedural time from femoral vein puncture to decannulation (skin-to-skin time)

  3. Fluoroscopy time

    Time frame: Within procedure

    Time of patients' exposure to the real-time X-ray imaging during the procedure.

  4. Ablation time

    Time frame: Within procedure

    Radiofrequency delivery time during the procedure.

  5. Early onset complications

    Time frame: Within 30 days

    Complications within 30 days post-ablation, including death, myocardial infarction, diaphragmatic paralysis, stroke or transient ischemic attack, systemic embolism, pericardial effusion or tamponade requiring drainage, heart block, pericarditis, and vascular access complications requiring intervention.

  6. Late onset complications

    Time frame: within 12 months

    Complications detected any time during the follow-up, including severe pulmonary vein stenosis (>70%), and atrioesophageal fistula.

Sponsors and collaborators

Lead sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Other

Collaborators

  • Shanghai Chest Hospital
  • Shanghai East Hospital
  • Xuzhou Central Hospital

Registry information

Official study title

Addition of Six Short Ablation Lines on Pulmonary Vein Isolation Circumferences Reduces Recurrence Rate of Paroxysmal Atrial Fibrillation

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Dec 22, 2015
Registry last updated
Jun 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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